Challenges in Developing Anti-Drug Antibody Ligand Binding Assays
Posted on Wed, Nov 30, 2011 @ 06:07 AM
Challenges in Developing Anti-Drug Antibody Ligand Binding Assays. The 2011 EBF Open Symposium – Less is More was held on the 16-18 November at the Hesperia Tower hotel, Barcelona, with a focus on new trends in bioanalysis and new technology developments. The versatile and diverse program combined regulated bioanalysis themes with technological and scientific developments for small and large molecule bioanalysis. This year’s meeting attracted over 400 attendees with presentations from Novartis, GSK, Shire and many more.
Guidelines for Immunogenicity Testing
The guidelines for immunogenicity testing require that anti-drug antibody assays (ADA) are capable of detecting low affinity antibodies and are able to measure Ig isotypes whilst being tolerant of the presence of circulating drug. Furthermore, testing schemes need to incorporate confirmatory assays and functional characterisation, typically a neutralisation assay. Having appropriate positive (and negative) control antibodies is crucial to being able to develop good ADAs, but in most cases it is only possible to use surrogate antibodies raised in different species.
Challenges in Developing Anti-Drug Antibody Ligand Binding Assays
During day 1 of the meeting Andrew Roberts, Sector Manager within Bioanalytical Sciences at Quotient Bioresearch presented on Challenges in Developing Anti-Drug Antibody Ligand Binding Assays. This presentation addressed the above requirements using examples of direct binding, bridging and semi-homogenous formats to illustrate how suitable ADAs can be developed. Amongst the challenges faced developing assays to measure IgE ADA responses, assays with poor drug tolerance, assays to PEGylated biopharmaceuticals and assays to protein analogues with endogenous counterparts. The presentation included case studies to demonstrate how to achieve good assay sensitivity and dynamic range for a range of target types including anti-PEGylated drugs. Request a copy of the presentation below:
